A Phase I Study in Resminostat monotherapy and S-1/Resminostat therapy in Patients with biliary tract or pancreatic cancer
- Conditions
- biliary tract camcer or pancreatic cancer
- Registration Number
- JPRN-jRCT2080222812
- Lead Sponsor
- Yakult Honsha Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 44
(1)Patients with unresectable/recurrence biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic bile duct carcinoma, gallbladder carcinoma and ampulla of Vater carcinoma) or unresectable/recurrence pancreatic cancer
(2)Patients who have received more than one regimen systemic chemotherapy history for biliary tract cancer or pancreatic cancer
(3)Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
(4)Patients who are able to ingest resminostat orally and have no gastrointestinal disturbance that, in the judgment of the investigator, may affect the absorption of resminostat
(1)Patients who have taken HDAC inhibitor
(2)Pregnant women or lactating mothers
(3)Patients with brain metastases or suspected brain metastases based on the clinical symptoms
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method Efficacy, Pharmacokinetics